BEUDAMED
    MDR MDR QMS Issued

    2022-MDR/QS-018

    Manufacturer: HEALTHIUM MEDTECH LIMITED
    Basic UDI-DIs
    0
    Scopes
    7
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    00
    432
    Valid for 432 days
    Expiry: August 15, 2027

    Basic Information

    Number
    2022-MDR/QS-018
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 15, 2022
    Expiry Date
    August 15, 2027
    Revision
    00
    Manufacturer
    HEALTHIUM MEDTECH LIMITED

    Certificate Lifecycle

    August 15, 2022 August 15, 2027

    Device Characteristics

    Sterile

    Scopes

    7 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    LATEX FOLEY BALLOON CATHETER 2-WAY & 3-WAY

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.